- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07610915
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Přehled studie
Postavení
Podmínky
Detailní popis
This project aims to address an important gap in paediatric postoperative care. Children recovering in the post-anaesthesia care unit (PACU) are commonly assessed using physiologic discharge-readiness criteria, which focus mainly on safety parameters such as consciousness, breathing, circulation, and readiness to leave PACU. Although these measures are essential for clinical decision-making, they do not fully capture the child's actual recovery experience, including symptoms such as pain, nausea or vomiting, distress, discomfort, tiredness, or poor behavioural recovery. As a result, two children may both meet discharge criteria yet have very different quality of recovery.
At present, there is no well-established child-centred questionnaire designed specifically to measure quality of recovery during the immediate PACU period. This project therefore aims to develop and test a new questionnaire that better reflects what matters to children, families, and clinicians during early recovery after anaesthesia and surgery.
The study will include children aged 2-17 years undergoing elective procedures requiring anaesthesia or sedation, with parent/caregiver proxy reporting used where appropriate for younger children. This is a multicentre collaboration. The Siriraj Hospital site will be involved in Step 1, the qualitative item-generation phase, and Step 4, the field-testing / survey administration phase. In Step 1, interviews with children, parents/caregivers, and clinicians will identify the most important aspects of recovery. In Step 4, the questionnaire will be tested in PACU and compared with routinely collected clinical indicators. The expected outcome is a practical, reliable, and child-centred PACU recovery measure for use in clinical care, quality improvement, and future research.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Issada Jindawatthana, MD.
- Telefonní číslo: +66624196194
- E-mail: issada.j@gmail.com
Studijní místa
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Bangkok
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Bangkok Noi, Bangkok, Thajsko, 10700
- Siriraj Hospital
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Kontakt:
- Issada Jindawatthana, MD.
- Telefonní číslo: 0624196194
- E-mail: issada.j@mahidol.ac.th
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion criteria
- Children aged 8-17 years for self-report version
- Parents/caregivers of children aged 2-7 years for proxy-report version
- Elective surgery/procedure under anaesthesia
- Planned recovery in PACU
- ASA I-IV
- Able to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
- Informed consent/assent obtained as applicable Exclusion criteria
- Unable to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
- Urgent or emergency surgery/procedure
- Not planned to recover in PACU, including planned direct transfer from theatre to ICU
- Developmental delay or other condition limiting comprehension for interview participation or questionnaire completion
- Not available for an uninterrupted interview or questionnaire completion.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Children
Children aged 8-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation.
Participants will complete study assessments relating to early recovery in the post-anaesthesia care unit (PACU).
This is an observational study and no intervention is assigned.
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Parent/caregiver
Parents or primary caregivers of participating children, or of children aged 2-7 years where proxy reporting is required.
Participants will provide proxy-reported assessments about their child early recovery phase.
This is an observational study and no intervention is assigned.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PedsQoR-PACU questionnaire score
Časové okno: Perioperative/Periprocedural (Day of surgery)
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The primary outcome is the PedsQoR-PACU questionnaire score, a measure of early postoperative recovery in children in the post-anaesthesia care unit (PACU).
The questionnaire will be completed either by the child (self-report, where age-appropriate) or by a parent/caregiver (proxy report, where applicable).
Higher scores will indicate better quality of recovery.
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Perioperative/Periprocedural (Day of surgery)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Internal consistency of the PedsQoR-PACU questionnaire
Časové okno: Perioperative/Periprocedural (Day of surgery)
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Internal consistency of the PedsQoR-PACU questionnaire will be evaluated using Cronbach's alpha.
Higher values indicate greater internal consistency among questionnaire items.
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Perioperative/Periprocedural (Day of surgery)
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Test-retest reliability of the PedsQoR-PACU questionnaire
Časové okno: Perioperative/Periprocedural (Day of surgery)
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Test-retest reliability will be assessed in a subset of participants who complete a repeat assessment at T2b. Reliability will be evaluated using appropriate agreement statistics.
Higher values indicate greater stability of repeated scores.
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Perioperative/Periprocedural (Day of surgery)
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Child-parent agreement for the PedsQoR-PACU questionnaire score
Časové okno: Perioperative/Periprocedural (Day of surgery)
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Agreement between child self-report and parent proxy report will be assessed when both are available at the same PACU time point.
Agreement will be evaluated using appropriate agreement statistics, such as intraclass correlation coefficients or weighted kappa.
Higher values indicate better agreement.
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Perioperative/Periprocedural (Day of surgery)
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Construct validity of the PedsQoR-PACU questionnaire score
Časové okno: Perioperative/Periprocedural (Day of surgery)
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Construct validity will be examined by assessing associations between PedsQoR-PACU scores and relevant clinical indicators of PACU recovery, such as pain scores, rescue analgesia, postoperative nausea/vomiting, respiratory support, airway events, and PACU length of stay.
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Perioperative/Periprocedural (Day of surgery)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 433/2569(IRB4)
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